Happy Presidents’ Day

Happy Presidents’ Day

From Washington, DC

From the public health and medical research front,

  • ABC News reports,
    • “Half of all states are seeing high levels of respiratory virus activity, new federal data updated Friday shows.
    • “Currently, 25 states plus New York City and Washington, D.C., are experiencing “high” or “very high” levels of respiratory illness activity, according to the Centers for Disease Control and Prevention (CDC).
    • “While this is higher than the 23 states experiencing “high” or “very high” activity levels last week, it is fewer than the peak of 38 states reporting “high’ or ‘very high’ levels the week ending Dec. 30. * * *
    • “Adults over age 65 continue to have the highest rates of both COVID and flu hospitalizations.”
  • Fortune Well informs us,
    • “Vaccines that protect against severe illness, death and lingering long Covid symptoms from a coronavirus infection were linked to small increases in neurological, blood, and heart-related conditions in the largest global vaccine safety study to date.
    • “The rare events — identified early in the pandemic — included a higher risk of heart-related inflammation from mRNA shots made by Pfizer Inc., BioNTechSE, and Moderna Inc., and an increased risk of a type of blood clot in the brain after immunization with viral-vector vaccines such as the one developed by the University of Oxford and made by AstraZeneca Plc. 
    • “The viral-vector jabs were also tied to an increased risk of Guillain-Barre syndrome, a neurological disorder in which the immune system mistakenly attacks the peripheral nervous system.”
  • and
    • “They say anything men can do, women can do better—which may include reaping the health benefits of regular exercise. That’s according to a new study published today in the Journal of the American College of Cardiology.
    • “An international team of researchers from the U.S. and China showed that women who exercise regularly have a significantly lower risk of an early death or a fatal cardiovascular event than men who do the same. On top of that, the advantage holds true even when women put in less effort.
    • “The observational study, which analyzed the exercise habits of more than 400,000 U.S. adults, found that compared to being inactive, engaging in regular physical activity lowered women’s mortality risk by 24%. Men saw a 15% reduction in risk.
    • “Women who worked out also had a 36% reduced risk of a fatal cardiovascular event, such as a stroke or heart attack, than their inactive peers. Among men, those who were physically active showed a 14% reduced risk.”
  • The Washington Post reports,
    • “About 1 in 4 U.S. adults 65 and older — more than 14 million people — suffer a fall each year, according to the Centers for Disease Control and Prevention.
    • “Falls are the leading cause of injury among those 65 and older, even though not all falls result in an injury, the CDC says. About 37 percent of older people who have fallen have sustained an injury that required medical treatment or activity restrictions. For instance, the CDC reports that 95 percent of hip fractures result from a fall, and falls also are the most common cause of traumatic brain injuries.
    • “The National Institute on Aging notes that the odds of falling increase with age, but falls often can be prevented. Standard suggestions include fall-proofing your home space (making sure all stairs have hand rails and are well-lit, eliminating most throw rugs and keeping walk spaces clutter-free), careful management of medications (especially those that can cause dizziness or confusion), having regular vision checks and staying as active as possible (including doing exercises to maintain strength and balance).”
  • STAT News tells us,
    • “Niacin, or vitamin B3, has long been a U.S. public health darling to the point that it is added, by law, to cereal products. But a new study published Monday in Nature Medicine points to a potentially concerning effect of an excess of the vitamin: It may increase the risk of cardiovascular disease.
    • “The study looked into two cohorts of patients without active heart disease, 60% of whom were treated with statins, and found a strong association between a metabolic product of excess niacin and an increased risk of major adverse cardiovascular events such as a heart attack or stroke. One in four of the people in the study had excess niacin, which doubled their risk of major cardiovascular events to levels comparable with diabetes or a previous heart attack.
    • “It’s a fairly sizable risk. It’s on par with what we consider other large risks,” said Stanley Hazen, the section head of preventive cardiology and cardiac rehabilitation at the Cleveland Clinic and senior author of the study. “This opens up the door; it lays the foundation for new studies and new interventions from both a diagnostic and therapeutic perspective to try to reduce inflammation and cardiovascular disease.”
  • Per Medscape,
    • “A plant-based diet, low in dairy and meat but rich in fruits, vegetables, grains, and nuts, can improve sexual and urinary health in patients treated for local prostate cancer, new research showed.
    • “The findings, published on February 13, 2024, in the journal Cancer, bolster previous research showing plant-based diets can reduce the risk for recurrence and improve survivorship in men with prostate cancer.
    • “The current study shows for the first time an association between eating more plant-based food with better scores for quality of life among patients diagnosed with prostate cancer,” Stacy Loeb, MD, a urologist in the Departments of Urology and Population Health at NYU Langone Health, in New York City, who led the research.”
  • and
    • Cefepime-taniborbactam was 22% more effective than meropenem, which is a current treatment for complicated urinary tract infections (UTIs) and acute pyelonephritis, according to a study published in The New England Journal of Medicine.

From the healthcare business front,

  • The Wall Street Journal reports,
    • “China has more obese people than anywhere else in the world, and they are increasingly turning to weight-loss drugs to solve the problem.
    • “That is fueling a gray market of drug sellers and buyers, who have little trouble getting around China’s rules on the use of Ozempic. 
    • “Ozempic isn’t available for weight loss in the country, instead being reserved for the treatment of Type 2 diabetes. But users on e-commerce platforms are able to buy the shots, colloquially known as “miracle drugs,” simply by declaring they have been diagnosed with diabetes—without providing proof. 
    • “They aren’t getting a bad deal: On JD.com, a dosage of Ozempic retails for around $139. That is higher than its cost on the country’s national-insurance plan but much cheaper than the $970 some users pay in the U.S. each month. JD.com didn’t respond to requests for comment.”
  • NPR Shots notes,
    • “Bayer is the latest name-brand drugmaker to dip its toe into the world of Mark Cuban’s online pharmacy, Cost Plus Drugs. 
    • “The website offers drugs at steep discounts bypassing middlemen called pharmacy benefit managersIt mostly sells generics, but has been slowly adding brand name products as well. 
    • “Yaz birth control pills and Climara, a hormone patch for menopause, will both now be available for a fraction of their list prices, including Cost Plus’s standard 15% markup and shipping.
    • “As I look at our partnership with Cost Plus, I really look at this as a test and learn,” says Sebastian Guth, president of U.S. Pharmaceuticals at Bayer. “It’s a first initial step. We will learn and see what the results of this partnership are and may then decide to expand it further.”
  • Beckers Payer Issues points out,
    • “Some health systems are getting out of the insurance business. 
    • “In the first weeks of 2024, two health systems announced plans to sell their health insurance subsidiaries. In February, Springfield, Mass.-based Baystate Health reached a deal to sell Health New England to Point32Health. 
    • “In January, Toledo, Ohio-based ProMedica said it planned to sell its insurance subsidiary, Paramount Health, to Medical Mutual of Ohio. 
    • “Baystate Health has around 180,000 members in Medicare, Medicaid and commercial, and Paramount Health has more than 77,000 members in Medicare Advantage, commercial, individual and short-term plans. Both are set to be acquired by larger nonprofit insurers. Point32Health and Medical Mutual of Ohio each have over 1 million members.” 

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Federal Times reports,
    • “It took 13 years — with some stops, starts and stumbles in between — but as of today, the federal government now has a single website designed to deliver detailed, searchable information about all federal programs.
    • “The Office of Management and Budget flipped the switch Thursday on the new Federal Program Inventory, a platform it’s been building via various pilot efforts since December 2020. Officials acknowledge it doesn’t yet capture every single program: For now, only “domestic assistance” programs are included. But that broad category encompasses most federal spending, ranging from Social Security and Medicare to the smallest community block grant programs.
    • “As of now, the database includes spending and performance data on 2,388 programs, said Diedre Harrison, OMB’s deputy controller.”
  • The FEHBlog cannot locate the FEHBP in this database, FYI. What’s more,
    • “The Treasury Department and the IRS are calling on teleworking employees to return to the office for half of their workdays, starting in a few months.
    • “IRS Commissioner Danny Werfel told employees in an email Thursday that teleworking employees will need to return to the office 50% of the time, on any given month, starting on May 5.
    • “Our top priority, regardless of where employees are located at any point in time, will continue to be meeting our goals of serving taxpayers, ensuring tax compliance and maintaining our vital technology and operations,” Werfel wrote.
    • “The return-to-office plans will only impact IRS executives, managers and non-bargaining unit employees with telework agreements in the National Capital Region. The decision affects IRS headquarters, the agency’s New Carrollton Federal Building and other offices in the Washington, D.C. area.”
  • Healthcare Dive points out,
    • “The federal government received 13 times more surprise billing disputes in the first half of 2023 than it expected to receive in a full year, according to new CMS data.
    • “And the amount is growing each quarter, contributing to a growing backlog and straining the capacity of the system regulators set up to arbitrate disputes over medical bills between providers and health insurers.
    • “Of the 288,810 disputes filed in the first six months of 2023, fewer than half were closed, and arbiters rendered payment decisions in under a third of cases. Of those, providers won 77% of payment determinations, while health plans prevailed in 23% — noteworthy statistics given providers have argued the arbitration process is unfairly weighted toward insurers.”
  • The Commonwealth Fund discusses the status of creating a separate version of the No Surprises Act for ground ambulances.
  • Newfront fills us in on federal claim substantiation rules for flexible spending accounts, health reimbursement accounts, and health savings accounts.
  • The Wall Street Journal reports,
    • “Novartis and Roche Holding said the U.S. Food and Drug Administration approved their Xolair treatment to reduce allergic reactions following the exposure to one or more foods.
    • “The pharmaceutical companies on Friday said Xolair has been approved for patients aged one year and older with the IgE-mediated food allergy.
    • “Patients taking Xolair for food allergies should continue to avoid all foods they are allergic to, the companies added.
    • “Xolair, a prescription biologic medicine that is given as an injection, shouldn’t be taken as an emergency treatment for allergic reactions.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration will decide by June 21 whether to loosen the restrictions surrounding use of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, the company said Friday
    • “Sarepta’s gene therapy, Elevidys, was granted a conditional OK last June for children between 4 and 5 years of age who have Duchenne and can still walk. Sarepta aims to convert that nod to a full approval for all people with Duchenne and a confirmed mutation to a specific gene, even though Elevidys failed to hit its main goal in a study meant to confirm its benefits. 
    • “Sarepta, for its part, has argued that the collective evidence it’s accrued proves Elevidys is impacting the disease. Analysts appear optimistic of its chances, given the agency won’t convene a group of outside experts to review its request.”  

From the public health and medical research front,

  • The Centers for Disease Control tells us
    • In September 2023, CDC’s Advisory Committee on Immunization Practices recommended updated 2023–2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. Many variants co-circulated during fall 2023; the JN.1 lineage became predominant in January 2024. Few estimates of updated 2023–2024 vaccine effectiveness (VE) are available.
    • What is added by this report?
    • Receipt of updated COVID-19 vaccine provided approximately 54% increased protection against symptomatic SARS-CoV-2 infection compared with no receipt of updated vaccine. Vaccination provides protection against JN.1 and other circulating lineages.
    • What are the implications for public health practice?
    • All persons aged ≥6 months should receive updated 2023–2024 COVID-19 vaccine. CDC will continue monitoring COVID-19 VE, including against severe disease and for expected waning.
  • The CDC called attention to its website on RSV prevention.
  • MedCity News offers
    • “Three Tips To Improve Health Plans’ Chronic Conditions Management 
    • “During a virtual panel, leaders from across the industry shared their advice on how health plans can do a better job of achieving their goals for chronic management. For example, one executive said health plans should utilize remote monitoring tools for centralized observation and be wary of using the wrong metrics.” 
  • Benefits Pro lets us know,
    • “Older Americans may forego elective surgeries because they are worried about out-of-pocket expenses and time away from work, along with potential exposure to COVID-19.
    • “This is according to a study by the University of Michigan Institute for Healthcare Policy and Innovation, which discovered that these factors tend to dissuade older Americans from going through with surgeries more than concerns about pain or the recovery process.
    • “Nearly half of those who said they were very concerned about cost and more than half of those who were very concerned about taking time off of work ended up not having a surgery they were considering, the study found. However, those who were concerned about surgery-related pain were just as likely as those with no concerns about pain to go ahead with surgery.”
  • Medscape calls attention to “How the New MRSA Antibiotic Cracked AI’s ‘Black Box.'”
    • “The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.
    • “Even with the AI’s assistance, there’s still a long way to go before clinical approval.
    • “But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.”
  • The New York Times reports,
    • “Growing numbers of children and adolescents are being prescribed multiple psychiatric drugs to take simultaneously, according to a new study by researchers at the University of Maryland. The phenomenon is increasing despite warnings that psychotropic drug combinations in young people have not been tested for safety or studied for their impact on the developing brain.
    • “The study, published Friday in JAMA Open Network, looked at the prescribing patterns among patients 17 or younger enrolled in Medicaid from 2015 to 2020 in a single U.S. state that the researchers declined to name. In this group, there was a 9.5 percent increase in the prevalence of “polypharmacy,” which the study defined as taking three or more different classes of psychiatric medications, including antidepressants, mood-stabilizing anticonvulsants, sedatives and drugs for A.D.H.D. and anxiety drugs.”
  • AP reports,
    • “Smoking has surpassed injecting as the most common way of taking drugs in U.S. overdose deaths, a new government study suggests.
    • “The Centers for Disease Control and Prevention called its study published Thursday the largest to look at how Americans took the drugs that killed them.
    • “CDC officials decided to study the topic after seeing reports from California suggesting that smoking fentanyl was becoming more common than injecting it. Potent, illicit versions of the painkiller are involved in more U.S. overdose deaths than any other drug.”

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “CommonSpirit Health cut its operating losses in the three months ended Dec. 31by working with payers to speed the rate of reimbursement for services and implementing cost containment measures, according to earnings released on Thursday.
    • “The Chicago-based health system reported an operating income of $356 million for the quarter. Normalized for the California provider fee program, CommonSpirit logged an operating loss of $87 million. In the same period last year, CommonSpirit reported an operating loss of $440 million.
    • “CommonSpirit said supply and salary inflation continues to vex the system. Salaries and benefit expenses increased $413 million, or 9.3%, year over year, primarily due to higher salary costs.”
  • RevCycle Intelligence adds,
    • “Rural healthcare’s outlook just worsened, according to a new analysis from Chartis, a healthcare advisory firm.
    • “The updated analysis of key indicators such as rural hospital operating margin, facility closures, and loss of access to care and services paints a grim picture for rural hospitals in the US, particularly independent providers.
    • “Half of rural hospitals are operating in the red, the analysis found, and that percentage increased from 43 percent a year ago. More independent rural hospitals are operating at a loss at 55 percent, while 42 percent of health system-affiliated rural hospitals have a deficit. The analysis noted that almost 60 percent of rural hospitals in the US are now affiliated with a health system.
    • “With more rural hospitals facing revenue losses, 418 facilities are “vulnerable to closure,” the analysis showed.
    • “America’s rural hospitals have been battling against drivers of instability for more than a decade, but this newest research suggests this crisis has accelerated quickly to previously unseen levels,” Michael Topchik, national leader of The Chartis Center for Rural Health, said in a statement. “To learn the percentage of rural hospitals in the red has shifted 7 [percent] and now includes half of all rural hospitals is startling and should serve as an urgent call to action for everyone invested in rural healthcare.”
  • Per Fierce Healthcare,
    • “Nearly all healthcare executives believe new digital health technologies are worth the cost, even though they have yet to see a financial return from it, a new survey reveals.
    • “The inaugural Health Pulse Survey was conducted by Ernst & Young and reached more than 100 payer and provider administrative executives across the U.S. It found that the appetite for digital health solutions has risen, particularly since COVID-19. The pandemic was a catalyst for the industry.
    • “COVID prompted a lot of digital health tech investments by payers and providers—it was out of necessity,” Kaushik Bhaumik, EY’s U.S. health technology leader, told Fierce Healthcare. “People had to connect with their patients through digital channels.” 
  • Reuters reports,
    • “A small but rapidly growing number of U.S. adolescents began treatment with Novo Nordisk’s weight-loss drug Wegovy last year, a powerful new tool to address record rates of pediatric obesity, according to data shared exclusively with Reuters.
    • “In the first 10 months of 2023, 1,268 children ages 12 to 17 with an obesity diagnosis started taking Wegovy, according to U.S. insurance claims data compiled by health technology company Komodo Health.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC

  • STAT News reports
    • “Lawmakers are considering increasing doctors’ Medicare pay in an upcoming government funding package, but their policy would only partially offset cuts providers saw earlier this year, three lobbyists and two sources familiar with the talks told STAT.
    • “Physicians’ groups have agitated for Congress to undo a roughly 3.4% Medicare pay cut this year, resulting from the expiration of pandemic-era bonuses lawmakers chose to give the industry.
    • “The cut went into effect on Jan. 1, but a fix hasn’t entirely fallen off of the agenda. A pay increase was discussed in negotiations over a stopgap funding bill earlier this year.
    • “There are more questions than answers at this point in negotiations. It’s unclear what the exact pay increase could be, when it could be passed, and how it could be paid for. The fate of legislation to fund the government is uncertain, too. But the five sources made it clear that an effort to completely offset the 3.4% cut is now off the table.”
  • The New York Times reports,
    • “The Centers for Disease Control and Prevention is considering loosening its recommendations regarding how long people should isolate after testing positive for the coronavirus, another reflection of changing attitudes and norms as the pandemic recedes.
    • “Under the proposed guidelines, Americans would no longer be advised to isolate for five days before returning to work or school. Instead, they might return to their routines if they have been fever free for at least 24 hours without medication, the same standard applied to the influenza and respiratory syncytial viruses.
    • “The proposal would align the C.D.C.’s advice with revised isolation recommendations in Oregon and California. The shift was reported earlier by The Washington Post, but it is still under consideration, according to two people with knowledge of the discussions.
    • “The C.D.C. last changed its policy on isolation in late 2021, when it scaled down the recommended period to five days from 10. If adopted, the new approach would signal that Covid has taken a place alongside other routine respiratory infections.”
  • The Federal Times tells us,
    • “The federal employee retirement backlog shot back up in January, snapping a four-month streak of steadily shrinking caseloads and indicating the government still has trouble getting a handle on its system for processing annuities.
    • “Nearly 13,000 people applied for retirement in January, matching the usual record-high number the Office of Personnel Management receives at the beginning of each calendar year. Traditionally, the retirement claims surge culminates in winter and case workers work through it well into spring.
    • “Last month, the Office of Personnel Management processed roughly 6,400 cases while intaking almost twice that. The overall inventory was 46% higher in January than December. And while processing times again improved last month after steadily quickening, it remains to be seen how the influx will impact speeds in the coming months.
    • “Despite the increases, fewer employees overall retired in 2023 than 2022, 2021 and 2020.”
  • The Society for Human Resource Management lets us know,
    • “Inflation fell in January to 3.1 percent year-over-year, missing some economists’ estimates that it would fall below 3 percent for the first time in nearly three years. 
    • “The Consumer Price Index (CPI) for all items rose 3.1 percent for the 12 months ending in January, before seasonal adjustment, the U.S. Bureau of Labor Statistics (BLS) reported today. That’s down from the unadjusted 3.4 percent annual gain seen in December—and a significant improvement from the 9.1 percent high notched in June 2022. 
    • “Core inflation—which accounts for all items minus food and energy—rose 3.9 percent over the past 12 months, the same for the 12 months ending in December.” 

From the public health and medical research front,

  • The New York Times reports,
    • “Women who develop high blood pressure or diabetes in the course of pregnancy are more likely to give birth to children who develop conditions that may compromise their own heart health at a young age, scientists reported on Monday.
    • “By the time they are 12 years old, these children are more likely to be overweight or to be diagnosed with high blood pressure, high cholesterol or high blood sugar, compared with children whose mothers had complication-free pregnancies.
    • “The research underscores the strong association between healthy pregnancies and child health, though the study stops short of proving a cause-and-effect relationship. The conclusions also offer support for the “fetal origins of adult disease” hypothesis, which suggests that many chronic conditions may have roots in fetal adaptations to the uterine environment.”
  • The American Hospital News points out,
    • “Syphilis infections during pregnancy more than tripled between 2016 and 2022 to 280 cases per 100,000 births, ranging from 46 per 100,000 in Maine to 763 per 100,000 in South Dakota, the Centers for Disease Control and Prevention reported Feb. 13. Rates doubled in seven states and grew fivefold in six states: New Mexico, Colorado, Mississippi, South Dakota, Montana and Alaska. Rates increased across all racial/ethnic and age groups, with the highest rates in mothers who were American Indian and Alaska Native, under age 25 and had no prenatal care.
    • “According to a CDC report last November, over 3,700 mothers passed the infection onto their babies in 2022, 10 times more than in 2012, although timely testing and treatment could prevent most mothers from transmitting the infection to their babies. Congenital syphilis can cause adverse pregnancy outcomes such as fetal and neonatal death, low birthweight, preterm birth, and brain and nerve disorders.”
  • The Wall Street Journal notes,
    • “At a biomedical center here, there’s a man scarfing down Frosted Flakes and tater tots while hooked up to an IV. His job? To help the government figure out what you should eat.
    • “That man, Kevin Elizabeth, a 28-year-old tech worker, is one of 500 Americans who will be living at scientific facilities around the country for six weeks, eating precisely selected meals and undergoing hundreds of medical tests. He is part of a new study, costing $189 million, that is one of the most ambitious nutrition research projects the National Institutes of Health has ever undertaken. * * *
    • “If all goes according to plan, in a few years you’ll be able to walk into your doctor’s office, get a few simple medical tests, answer questions about your health and lifestyle, and receive personalized diet advice, says Holly Nicastro, coordinator for the NIH’s Nutrition for Precision Health study.”
  • On the flip side, MedPage Today explains,
    • “Gastric bypass surgery in people with severe obesity was associated with sustained improvements in cognitive function, inflammation, and comorbidities, according to results of a cohort study in the Netherlands.
    • “At 2 years post-surgery, neuropsychological tests showed improvements of 20% or higher in global cognition (43% of patients), ability to shift attention (40%), episodic memory (32%), verbal fluency (24%), and working memory (11%), reported Amanda J. Kiliaan, PhD, of Radboud University Medical Center in Nijmegen, the Netherlands, and colleagues.
    • “Lower inflammation and adipokine secretion, remission of comorbidities, higher physical activity, and better mood” may have played a role in the sustained improvement in global cognition for that subset of patients, the researchers suggested in JAMA Network Open.”
  • The Washington Post illuminates “How D.C.’s first sobering center could ease drug and alcohol addiction. The facility, part of the District’s response to a worsening opioid epidemic, exceeded 1,000 admissions in just over three months since it opened late last year.”

From the U.S. healthcare business front,

  • Per a Cigna press release,
    • “Cigna Healthcare, the health benefits division of The Cigna Group (NYSE: CI), and HelloFresh*, the world’s leading meal kit company, announce an exclusive collaboration to offer discounted access to HelloFresh’s wholesome, affordable meals to as many as 12 million Cigna Healthcare customers through their employers. The two companies will also team up to support HelloFresh’s Meals with Meaning program, a social impact initiative that provides free meal kits for individuals experiencing food insecurity in local communities.
    • “Business leaders recognize that healthy employees mean a healthy business, and by expanding access to affordable, healthy meals, employers can better cultivate a stronger workforce,” said Heather Dlugolenski, U.S. commercial strategy officer, Cigna Healthcare. “We’re proud to team up with HelloFresh to support the health and vitality of America’s workforce and to make a difference for communities in need.”
  • Per Fierce Healthcare,
    • Chronic care provider Omada Health is expanding its GLP-1 program to better care for patients interested in maintaining weight loss progress while discontinuing usage of the drugs.
    • For patients prescribed to GLP-1 drugs for weight loss, up to 40% of the weight loss can be due to loss of muscle mass. Omada is building upon its weight management solution to help users regain muscle throughout a member’s journey and when the drug is no longer utilized, a solution that would improve health outcomes and allow patients to not stray far from weight-related goals. Members of Omada’s cardiometabolic programs can benefit from the expanded care track, the company said.
  • and
    • “Zocdoc has launched a new guided search to help patients choose and book the right provider with greater confidence. 
    • “The guided search function on the healthcare marketplace and appointment booking platform offers a more tailored set of results based on patients’ unique care needs. When a patient searches for a provider, they are presented with an optional questionnaire to help better understand their symptoms and the type of treatment being sought. The goal is to take the guesswork out of which provider is the best fit.
    • “This search function can also help patients discover more about a provider’s scope of practice and helps providers ensure the patient is a good fit, Zocdoc said. A broad spectrum of specialties have the function available.”
  • Beckers Hospital Review notes,
    • CVS’ Aetna will begin offering in-home care services to its Medicare Advantage members with chronic kidney disease. 
    • Aetna has partnered with Monogram Health, a provider of in-home care management services, according to a Feb. 13 LinkedIn post from Monogram. Under the partnership, Monogram nurse practitioners will provide in-home and virtual specialty provider appointments to eligible Aetna members. 

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

  • Think Advisor lets us know,
    • “The U.S. House of Representatives voted 211-208 on Wednesday to pass H.R. 485, the Protecting Health Care for All Patients Act of 2023.
    • “The bill would prohibit federal health programs — including Medicare, Medicaid and the Federal Employees Health Benefits Program — from using a “quality-adjusted life year” measure or similar measures when allocating resources.
    • “All Republicans who voted supported the bill, and all Democrats who voted opposed it.
    • “The bill was introduced by Rep. Cathy McMorris Rodgers, R-Ore.”
  • Roll Call reports,
    • “House Energy and Commerce Chair Cathy McMorris Rodgers, a 10-term Republican from Washington state who has been a strong advocate for people with disabilities, announced Thursday she would not seek reelection this year.
    • “It’s been the honor and privilege of my life to represent the people of Eastern Washington in Congress. They inspire me every day,’’ Rodgers said in a statement. “After much prayer and reflection, I’ve decided the time has come to serve them in new ways. I will not be running for re-election to the People’s House.”
    • “The announcement comes as Rodgers is leading negotiations with the Senate on a wide-ranging health care package that touches all parts of the industry. The legislation would implement more transparency in data and pricing for prescription drugs and other medical services.”
  • BioPharma Dive informs us,
    • “The CEOs of three major drugmakers defended the prices they charge U.S. patients in a Senate [Health Education Labor and Pensions] committee hearing Thursday, claiming Americans gain access to cutting-edge medicines months or years earlier than people in countries that pay a fraction of the U.S. costs. * * *
    • “Sen. Ben Ray Luján, D-N.M., asked the CEOs to pledge to not block entry of generics or biosimilars to the respective drugs in the spotlight when their primary patents expire, which Merck and Bristol Myers agreed to. That question in the case of Bristol Myers Squibb was focused Opdivo, its cancer immunotherapy rival to Keytruda.
    • “For Merck, Davis committed to open competition with any forthcoming biosimilars of intravenous Keytruda. But he didn’t mention the company is trying to develop and launch a subcutaneous, or under-the-skin, version that would likely extend its market advantage beyond the anticipated 2028 expiration of its main patent. Bristol Myers is also working on subcutaneous Opdivo.
    • “Questioned by Luján on settlements that have pushed the launch of biosimilar Stelara to 2025, J&J’s Duato said the price of the drug will be lower when that happens and added that prices net of rebates have dropped ahead of biosimilar competition.”
  • Bloomberg reports,
    • “The pharmaceutical industry, Trump and Obama administration officials, and others are urging the Biden administration to reconsider a controversial plan for seizing patents on a drug when its cost gets too high, claiming the approach misinterprets decades-old law and threatens the delicate pipeline that produces innovative, life-saving drugs.
    • “Over 500 comments were filed by the Feb. 6 deadline for groups and individuals to weigh in on the Biden administration’s framework for the federal government to use its march-in rights. The proposal lays out the Biden administration’s stance in a longstanding debate over whether price is a justifiable reason for the government to “march in” and take over a patent on technology developed with the help of taxpayer dollars and then license it to an outside manufacturer.
    • “The Biden plan is already drawing blowback from a broad swath of players in the innovation space. A collection of former US Patent and Trademark Office directors and other government officials under the George W. Bush, Obama, and Trump administrations wrote to warn that the proposed framework, if adopted, would prove destabilizing.”
  • Per an HHS press release
    • “The Department of Health and Human Services’ Office of Intergovernmental and External Affairs (IEA) will be hosting a stakeholder webinar TOMORROW, February 9, 2024, from 2 – 3 PM ET to provide an update on patient privacy.  
    • “Today, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), finalized modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 (“Part 2”), which protect the privacy of patients’ SUD treatment records. Specifically, today’s final rule increases coordination among providers treating patients for SUDs, strengthens confidentiality protections through civil enforcement, and enhances integration of behavioral health information with other medical records to improve patient health outcomes.
    • “Today’s rule was informed by the bipartisan Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that, among other things, required HHS to bring the Part 2 program into closer alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Breach Notification, and Enforcement Rules.
    • “The final rule includes the following modifications to Part 2:
      • “Permits use and disclosure of Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
      • “Permits redisclosure of Part 2 records by HIPAA covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions.
      • “Provides new rights for patients under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
      • “Expands prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings.
      • “Provides HHS enforcement authority, including the potential imposition of civil money penalties for violations of Part 2.
      • “Outlines new breach notification requirements applying to Part 2 records.”
    • “A fact sheet on the final rule may be found at: https://www.hhs.gov/hipaa/for-professionals/regulatory-initiatives/fact-sheet-42-cfr-part-2-final-rule/index.html
    • Register in advance for this webinar: REGISTER HERE  
  • Govexec tells us,
    • “The U.S. Postal Service was $2 billion in the red in the first three months of fiscal 2024—typically its busiest and most profitable period of the year—doubling its loss from the same period in the previous year. 
    • “The accelerated losses during the holiday season continue a longstanding trend of poor financial performance for the mailing agency, but mark a troubling sign as its leadership team undertakes significant operational transformations with a promise to right the ship.
    • “In a positive development, however, USPS turned a net profit of $472 million when accounting only for the part of the ledger postal management deems within its control. That figure, which does not include fluctuations in workers’ compensation and amortized payments toward employee retirement accounts, grew from $187 million in the first quarter of the prior year.” 
  • The U.S. Office of Personnel Management announced,
    • “[t]he Finalists for this year’s Presidential Management Fellows (PMF) Program, the federal government’s premier leadership development program. In total, 825 Finalists were selected from more than 7,000 applicants from around the world. 
    • “Presidential Management Fellows are the next generation of federal government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2024 PMF finalists. We cannot wait to see what you will accomplish in public service.” 

From the public health and medical research front,

  • Medscape points out,
    • “Brain fog is one of the most common, persistent complaints in patients with long COVID. It affects as many as 46% of patients who also deal with other cognitive concerns like memory loss and difficulty concentrating. 
    • “Now, researchers believe they know why. A new study has found that these symptoms may be the result of a viral-borne brain injury that may cause cognitive and mental health issues that persist for years.
    • “Researchers found that 351 patients hospitalized with severe COVID-19 had evidence of a long-term brain injury a year after contracting the SARS-CoV-2 virus. The findings were based on a series of cognitive tests, self-reported symptoms, brain scans, and biomarkers.” 
  • STAT News reports,
    • “People receiving a double dose of naloxone are no more likely to survive an opioid overdose than people receiving a standard, 4-milligram nasal spray, according to a new study.
    • “The new paper, published Thursday in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, showed no significant difference in survival rates between people who were revived using 4- and 8-milligram sprays of naloxone, commonly known by the brand name Narcan. People receiving the smaller dose also did not require a higher total number of sprays, despite having received just half the initial amount. The researchers found only one major contrast between those receiving different dose sizes: Those who received a double dose were over 2.5 times more likely to experience severe withdrawal symptoms, like vomiting.
    • “The study comes as pharmaceutical companies continue to market expensive high-dose formulations of naloxone, arguing that amid record drug death levels resulting from potent synthetic opioids like fentanyl, it’s essential to deliver as much of the overdose-reversal medication as possible. Public health experts and harm-reduction groups have pushed back, however, charging that the companies have used Americans’ fear of fentanyl as an excuse to sell needlessly expensive naloxone products to cash-strapped public health agencies.”
  • Beckers Hospital Review reports,
    • “Patients who take Ozempic, Mounjaro and Wegovy are less likely to be diagnosed with anxiety or depression compared to those who don’t receive the popular diabetes and weight loss drugs, according to a new study
    • “A review of more than 4 million patient records conducted by Epic Research found that diabetic patients are less likely to have anxiety if they are taking any glucagon-like peptide-1 receptor agonist. 
    • “The researchers analyzed five different GLP-1s: tirzepatide (Mounjaro, Zepbound), semaglutide (Ozempic, Wegovy, Rybelsus), dulaglutide (Trulicity), liraglutide (Saxenda, Victoza) and exenatide (Byetta, Bydureon). 
    • “The patients taking GLP-1s for weight loss were compared with those receiving another kind of weight loss drug, and diabetic patients were compared with people not taking a GLP-1.”
  • The American Hospital Association News notes how you can “[l’earn how hospitals and health systems are improving maternal and child health outcomes in this synopsis of the latest resources from AHA’s Better Health for Mothers and Babies initiative. READ MORE.”
  • The NIH Director discusses in her blog “What’s Behind that Morning Migraine? Community-Based Study Points to Differences in Perceived Sleep Quality, Energy on the Previous Day.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • AstraZeneca sees its revenue and core earnings per share growing by double-digit percentages in 2024, the pharmaceuticals major said as it reported fourth-quarter core earnings per share below expectations on higher costs, sending the stock lower.
  • CNBC discusses how “Novo Nordisk, Eli Lilly are tackling weight loss drug supply woes.”
    • “Last week, the Danish drugmaker [Novo Nordisk] said it had more than doubled its supply of lower-dose versions of its weight loss injection Wegovy in January compared to previous months. Supply shortages forced Novo Nordisk to restrict the availability of those lower doses in the U.S. since May. 
    • “But why are those lower doses important? It’s because people are supposed to start Wegovy at a low dose and gradually increase the size over time to mitigate side effects such as nausea. So, more of those low “starter” doses means more new patients can begin treatment with Wegovy. 
    • “The company plans to “gradually” increase the overall supply of Wegovy throughout the rest of the year, executives added on the company’s fourth-quarter earnings call Wednesday.”
  • Per Healthcare Dive,
    • “UnitedHealth’s chief operating officer Dirk McMahon is retiring after more than two decades at the company.
    • McMahon plans to retire on April 1, the payer said in a Wednesday filing with the Securities and Exchange Commission on Wednesday.
    • “UnitedHealth has yet to name a replacement for McMahon.”
  • and
    • “Walgreens has named a new head of its healthcare unit as the pharmacy chain works to improve its halting finances and shift to delivering more healthcare services.
    • “John Driscoll, the current executive vice president and president of the U.S. Healthcare segment, will be replaced by Mary Langowski, who previously held the chief executive role at chronic condition management company Solera Health. Driscoll will serve in a senior advisory role, Walgreens announced Thursday.”
  • and
    • “Molina Healthcare lost half a million Medicaid members due to redeterminations by the end of 2023, executives said Thursday.
    • “States resumed checking beneficiaries’ eligibility for the safety-net program in April following a pause during the COVID-19 public health emergency. Some 16 million Americans have been disenrolled from Medicaid to date because of the redeterminations. The process is disproportionately impacting insurers with a heavy Medicaid presence like Molina, which brings in 80% of its revenue from the program.
    • “Molina still expects to retain 40% of its Medicaid membership once redeterminations are complete. However, on Thursday the insurer raised its estimate of members gained during COVID from 800,000 to 1 million because of new business adds. That implies a net member loss of 600,000 once redeterminations are complete.” 
  • and
    • “Tenet Healthcare beat Wall Street expectations for revenue in the fourth quarter of 2023 on continued cost control measures and sustained demand for services, particularly in its ambulatory care unit, executives said during an earnings call on Thursday.
    • “CEO Saum Sutaria told investors that Tenet was entering a “new era” in which a higher proportion of its performance was generated by its ambulatory surgical business. Same-facility revenue for ambulatory services grew 9.2% during 2023, above Tenet’s long-term goal of 4% to 6% top line growth.
    • “The Dallas-based for-profit will continue a careful watch on its debt levels, executives said. The company has recently taken steps to reduce its leverage, last week finalizing the sale of three hospitals to Novant Health and announcing the sale of four additional hospitals to UCI Health.”
  • Beckers Payer Issues discusses why it appears that insurers are split in two camps over rising Medicare Advantage costs.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The FEHBlog listened to the House Oversight and Accountability Committee’s markup of HR 6283, the Delinking Revenue from Unfair Gouging Act. Is there such as thing as fair gouging? In any case, the FEHBlog was relieved by the amount of bipartisan opposition to the bill. However, as explained in this STAT News article, the Committee Chairman James Comer (R Ky) steered an amended version of the original bill through his Committee this morning. Like Committee members with doubts about the bill, the FEHBlog looks forward to the Congress Budget Office report on the measure.
  • The American Hospital Association (AHA) News reports
    • “In a statement submitted to the House Ways and Means Committee for a hearing Feb. 6 on chronic drug shortages, AHA recommended Congress enact legislation to diversify manufacturing sites and sources for critical pharmaceutical ingredients; support an increase in end-user and supply chain inventories for critical medications; develop a rating system for drug maker quality management processes; identify essential drugs needing more domestic manufacturing capacity; and require drug makers to disclose where their products are made and when demand for essential drugs spikes.” 
  • and
    • “The Health Resources and Services Administration Feb. 6 requested vendor proposals to support changes to governance, technology and operation of the Organ Procurement and Transplantation Network, as authorized by Congress last year. HRSA also directed the current OPTN vendor, the United Network for Organ Sharing, to standardize and update data reporting for greater accountability and equity in organ procurement and transplant practices. HRSA indicates that the scope and scale of the contract awards will be contingent on final 2024 appropriations.”
  • The Department of Health and Human Services announced,
    • releasing the National Public Health Strategy to Prevent and Control Vector-Borne Diseases in People (VBD National Strategy). As directed by the 2019 Kay Hagan Tick Act—named after the U.S. Senator who died due to complications from a tickborne illness—HHS led a four-year process with civilian agencies and defense departments to deliver this strategy. Co-led by the HHS Office of the Assistant Secretary for Health and the Centers for Disease Control and Prevention, the strategy identifies and describes federal priorities to detect, prevent, respond to, and control diseases and conditions caused by vectors in the United States.
    • “Vector-borne diseases are a global threat, with national security, economic, and health implications for the United States. As the federal government continues to proactively strengthen its response to this threat, HHS and CDC plan to develop future iterations of the VBD National Strategy with opportunities for public engagement. Read the VBD National Strategy.”
  • Beckers Hospital Review tells us,
    • “Respiratory syncytial virus vaccinations could soon extend to adults aged 50-59. 
    • “Arexvy, which was initially approved by the FDA in May 2023 for administration in adults over 60, has been granted priority review in the U.S. for use in adults ages 50-59.
    • “If approved, it will become the first RSV vaccine available for the age group, according to a Feb. 6 news release. 
    • “The FDA is slated to make a decision on the drug’s approval for the new age group by June 7.”

From the public health and medical research front,

  • Medscape informs us,
    • “Lowering the recommended age for baseline prostate-specific antigen (PSA) would reduce prostate cancer deaths by about 30% in Black men without significantly increasing the rate of overdiagnosis, according to new screening guidelines from the Prostate Cancer Foundation.
    • “Specifically, baseline PSA testing in Black men should begin at age 40-45, sooner than current guidelines recommend, and should be followed by regular screening intervals, preferably annually, at least until age 70, a multidisciplinary panel of experts and patient advocates determined based on a comprehensive literature review.”
  • Per the Food and Drug Administration,
    • On Monday, the FDA issued an outbreak advisory warning consumers not to eat, sell, or serve recalled brands of cheeses, sour creams (cremas), or yogurts manufactured by Rizo Lopez Foods, Inc. The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multi-year, multistate outbreak of Listeria monocytogenes infections linked to queso fresco and cotija cheeses manufactured by Rizo Lopez Foods, Inc., of Modesto, California. There are 26 illnesses with 23 hospitalizations in 11 states. The firm has recalled several dairy products and has temporarily ceased the production and distribution of these products while their investigation is ongoing. The FDA’s investigation is ongoing, and the FDA will continue to update this advisory as information becomes available.”
  • Per KFF,
    • “About 1 in 5 adolescents report symptoms of anxiety or depression, according to a KFF analysis of a new federal survey of teen health.
    • “While some teens are getting mental health care, a significant share say they are not receiving the therapy they need due to costs, fear of what others will think, and/or not knowing how to get help.”
  • The American Medical Association lets us know what doctors wish their patients knew about iron deficiency.
  • Healio notes,
    • “Infants aged younger than 3 months and children with a history of prematurity experience the highest rates of hospitalization for respiratory syncytial virus, according to study findings published in Pediatrics.
    • “Last year, two new tools became available to combat RSV, the leading cause of infant hospitalization in the United States: a vaccine for pregnant people and a new monoclonal antibody.” * * *
    • “Most RSV-associated hospitalizations occurred in healthy, term infants,” Meredith L. McMorrow, MD, MPH,a researcher in the CDC’s Coronavirus and Other Respiratory Viruses Division said. “This is why allbabies need protection from either maternal RSV vaccination or nirsevimab during their first RSV season.”
  • Beckers Hospital Review offers five Ozempic updates.

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Sales of Eli Lilly’s diabetes drug Mounjaro exceeded $5 billion in 2023, its first full year on the market, the company said Tuesday, in the latest sign of surging demand for the therapy and other medicines of its kind.
    • “Mounjaro’s fast launch helped drive Lilly’s revenue last year to $34 billion, a 20% increase over 2023. Fourth quarter revenue of $9.4 billion eclipsed analysts’ consensus expectations by 5%, Leerink Partners’ David Risinger wrote in a note to clients.
    • “Lilly said Mounjaro now accounts for 27% of total prescriptions in the U.S. for injectable “incretins,” the fast-selling group of drugs that work by modulating hormones that control insulin production. Sales of an older drug in this class, Lilly’s Trulicity, fell 4% in 2023 to $7 billion, but still led Lilly’s business.
    • “The obesity drug Zepbound, which contains the same active ingredient as Mounjaro, launched in the fourth quarter and brought in sales of $176 million through Dec. 31.”
  • STAT News adds,
    • “Eli Lilly reported during its fourth-quarter earnings call that tirzepatide, which is sold commercially as Mounjaro or Zepbound, succeeded in a Phase 2 test as a treatment for the liver disease MASH. Around 74% of adults in the trial taking the drug were free of MASH after 52 weeks, compared to approximately 13% of the placebo group.”
  • Wait, there’s more from Bloomberg,
    • Eli Lilly & Co.’s blockbuster diabetes drug Mounjaro, which is commonly used off-label for weight loss, is again in short supply due to increased demand.
    • “There will be limited availability of higher doses of the treatment through early March, according to a US Food and Drug Administration database that tracks shortages. So far, the FDA doesn’t list Mounjaro’s sister drug Zepbound, which is approved for weight loss, on its shortage list, though the two contain the same active ingredient.
    • “The company is continuing to ship all doses to wholesalers, but anticipates intermittent backorders of higher doses over the next month, a Lilly spokesperson said in an emailed statement. 
    • “We recognize this situation may cause a disruption in people’s treatment regimens and we are moving with urgency to address it,” the spokesperson said.”
  • BioPharma Dive points out
    • “The Japan-based pharmaceutical firm Eisai had hoped that, by the end of March, 10,000 patients in the U.S. would be taking its closely watched drug for Alzheimer’s disease. But that goal now seems lofty, following updates in the company’s latest earnings report.
    • “Eisai developed the drug, called Leqembi, in partnership with Biogen, and is leading its commercialization. As with an earlier Alzheimer’s therapy from the two companies, Leqembi’s launch started off slow. Yet Eisai and Biogen have argued that recent decisions from drug regulators and insurers should significantly increase both prescriptions and sales.
    • “Still, growth doesn’t appear to be coming as quickly as the companies want. Eisai recorded 1.1 billion yen, or roughly $7.4 million, in revenue from Leqembi between October and December — around half of what Wall Street analysts had generally expected, according to Michael Yee of the investment bank Jefferies.
    • The company also said Leqembi had been administered to a total of 2,000 U.S. patients as of Jan. 26, with another 8,000 or so on a waiting list. Eisai maintains the 10,000 patient milestone could be hit in a few months, though the team at Jefferies believes it might take longer “given launch dynamics have been slow to begin with.”
  • Beckers Hospital Review reports,
    • “San Francisco-based UCSF Health has signed a $100 million definitive agreement with San Francisco-based Dignity Health to take on two of its hospitals: Saint Francis Memorial Hospital and St. Mary’s Medical Center, both of which are in the city.”San Francisco-based UCSF Health has signed a $100 million definitive agreement with San Francisco-based Dignity Health to take on two of its hospitals: Saint Francis Memorial Hospital and St. Mary’s Medical Center, both of which are in the city.
    • UCSF Health began acquisition talks with Dignity Health, part of Chicago-based CommonSpirit Health, for the two hospitals in July. 
    • “Under the acquisition, which UCSF Health hopes to close by this spring, the hospitals will be renamed UCSF Health Saint Francis Hospital and UCSF Health St. Mary’s Hospital, respectively, according to a Feb. 5 UCSF news release.”
  • Per Healthcare Dive,
    • “Providence will refund payments and forgive outstanding medical debt for nearly 100,000 low-income Washington residents to settle a 2022 lawsuit alleging the health system skirted its charity care obligations, according to a Thursday announcement from Washington Attorney General Bob Ferguson.
    • “The Renton, Washington-based operator will refund approximately $20 million to over 30,000 patients who were billed improperly and forgive $137 million for more than 65,000 additional patients, in what the AG called the “largest resolution of its kind in the country.”
    • “The settlement is the latest win for the AG, who has successfully brought other health systems into compliance with the state’s charity care law, which offers reduced or free medical care for approximately half of Washingtonians based on financial status.”
  • and
    • “Centene has become the second major health insurer to warn investors of an impending funding decrease in Medicare Advantage — if regulators finalize 2025 rates as proposed.
    • “New payment parameters released by the CMS last week would cause Centene’s MA rate to fall 1.3%, CFO Drew Asher said during a Tuesday morning call discussing the payer’s fourth-quarter earnings results.
    • “However, this dip is before Centene risk scores its enrollees, a process which should result in an overall increase in MA reimbursement next year, Asher said. Humana disclosed similar concerns in a filing with the Securities and Exchange Commission on Monday.”

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC,

  • Tomorrow at 10 am, the House Oversight and Accountability Committee will mark up several bills including the FEHB provisions in the DRUG Act, HR 6283. It’s unfortunate that the Committee did not hold a hearing on this disruptive bill. The FEHBlog will be listening to the markup.
  • The Federal Times informs us,
    • “A pair of contracts designed to improve the quality of care in Tricare’s civilian medical networks will take effect Jan. 1, 2025, according to defense officials.
    • “The contracts are moving forward following a Jan. 31 decision in the U.S. Court of Federal Claims affirming the Defense Health Agency’s choice of TriWest Healthcare Alliance as the Tricare West Region’s new manager, denying a protest lodged by incumbent contractor Health Net Federal Services last year.  * * *
    • “Humana Government Business, the incumbent contractor for Tricare’s East Region, will continue in that role under a new deal worth up to $70.8 billion.The new contracts for the two regions have a potential combined value of $136 billion over nine years.”
  • MedTech Dive lets us know
    • “FDA panel recommends new standards for pulse oximeters amid bias concerns.
    • “Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.”
  • and
    • “Hologic has received regulatory clearance to sell an artificial intelligence (AI)-enabled cervical cancer screening system in the U.S. 
    • “The product, the Genius Digital Diagnostics System, creates digital images of Pap test slides and uses an AI algorithm to identify cells that cytologists and pathologists should review.
    • “Hologic’s clearance, announced on Thursday, comes days after BD partnered with Techcyte to promote a digital, AI-enabled cervical cancer screening test that is yet to come to market.”

From the public health and medical research front,

  • Beckers Hospital Review tells us,
    • “Eli Lilly’s ingredient for Type 2 diabetes medication Mounjaro and its new weight loss drug, Zepbound, significantly lowered patients’ blood pressure by up to 10.6 mmHg, according to a new study published Feb. 5. 
    • “The study recruited about 500 adult patients with a body mass index at or more than 27, or the overweight range. Compared to a placebo, tirzepatide — the active pharmaceutical ingredient of Mounjaro and Zepbound — reduced blood pressure for participants taking 5, 10 and 15 milligrams each week. The patients were not diabetic and either had normal blood pressure or high blood pressure that was under control.” 
  • STAT News reports,
    • “Amgen is trying a unique strategy with its obesity drug candidate: testing whether it can wean patients toward lower or less frequent doses over time.
    • “Very early data hints that Amgen’s candidate, called MariTide, may provide longer-lasting weight loss than highly popular obesity drugs on the market like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. Amgen is already seeing if that means its drug could also be dosed differently from Novo and Lilly’s products, which are costly and expected to be taken consistently for life.
    • “In an ongoing Phase 2 trial, Amgen’s researchers will first titrate participants up on MariTide, but then after some time, see if the drug can still be effective when transitioning patients to a less intensive dosing regimen, executives said in an interview.
    • “Could there be an opportunity for an induction maintenance-type of strategy for a molecule like MariTide?” said Narimon Honarpour, senior vice president of global development at Amgen, referring to a strategy used for anti-inflammatory drugs in which high, rapid doses are given at the start and then lower or less frequent doses are used for maintenance in the long run.”
  • HHS’s Agency for Healthcare Research and Quality released a rapid evidence report about deprescribing to reduce medical harms in older adults.
    • “Deprescribing has emerged as a clinical practice to reduce polypharmacy and use of potentially inappropriate medications (PIMs) and serve as a mechanism for quality improvement and increased patient safety. The purpose of this rapid response is to summarize recent literature on the use of deprescribing to improve the safety of medication use among older adults (age ≥ 65 years).”
  • CBS News reports,
    • “Preterm and early-term births in the U.S. have increased from 2014 to 2022, raising risks to babies, according to new data from the Centers for Disease Control and Prevention.
    • Data released Wednesday from the CDC’s National Center for Health Statistics shows the preterm birth rate — meaning delivery before 37 completed weeks of pregnancy — rose 12% during that time period, while early-term birth rates, at 37 to 38 completed weeks, rose 20%. 
    • “This is compared to full-term births, which are those delivered at 39 to 40 weeks.
    • “Using data from the National Vital Statistics System, the analysis only looks at singleton births, since multiple births like twins and triplets tend to be born at earlier gestational ages, the authors note.
    • “Gestational age is a strong predictor of short- and long-term morbidity and early mortality,” the authors write. “Births delivered preterm are at the greatest risk of adverse outcomes, but risk is also elevated for early-term compared with full-term births.”
  • MedCity News points out,
    • “Mayo Clinic has entered into a collaboration with TruLite Health — Mayo is helping the Phoenix-based startup develop its software platform designed to address providers’ clinical bias. The health system said it chose to collaborate with TruLite because of the platform’s potential to mitigate health inequities and enhance patient outcomes at the point of care.”
  • Per Fierce Healthcare,
    • “Artificial intelligence can help identify easy to miss patients who might be good candidates for a palliative or hospice care referral, a recent pilot at Mass General Brigham (MGB) revealed.
    • “The results of the findings were presented Friday at the Value-Based Payment Summit.
    • “Timely end-of-life care benefits patients. Patients and their families may also be more open to a conversation about goals of care during a hospital stay, MGB said in presentation slides shown to Fierce Healthcare.” 

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Holdings, the controlling shareholder of Danish drugmaker Novo Nordisk, will buy contract manufacturer Catalent for $16.5 billion in a take-private deal the companies announced Monday.
    • “In a related transaction, Novo Nordisk has agreed pay its parent company $11 billion to take over three Catalent plants in Italy, Belgium and Indiana to help expand production of its GLP-1 drugs Ozempic and Wegovy. Demand for the latter, which is approved in the U.S. for treating obesity, has greatly exceeded supply, forcing Novo Nordisk to restrict access.
    • “Novo Nordisk and Catalent already work together at the three sites, which employ more than 3,000 staff.”
  • and
    • “On Monday, Johnson & Johnson said one of its most closely watched experimental medicines appears to have positive effects on two autoimmune diseases, providing further support to a drug that, by the company’s estimates, could eventually generate billions of dollars in annual sales.
    • “J&J didn’t release any data, but rather said the drug hit the main goals of a mid-stage clinical trial testing it in patients with Sjögren’s disease as well as a late-stage study focused on generalized myasthenia gravis, a rare condition known in short as gMG. The company plans to present more detailed results from both studies at upcoming medical meetings, and to engage with regulators about the path to approval in gMG.”
  • Per Healthcare Dive,
    • “Cano Health filed for Chapter 11 bankruptcy late Sunday, as the beleaguered primary care chain works to bolster its financials. 
    • “The filing is part of a restructuring support agreement with the majority of its lenders. Cano said it expects to emerge from restructuring during the second quarter this year, adding that the process will help it reduce debt and allow it to search for a strategic partner or buyer.
    • “Cano also announced it reached an agreement to receive $150 million in debtor-in-possession financing to fund its operations during restructuring.”
  • and
    • “Medicare Advantage rate changes proposed by regulators last week are upsetting Humana’s funding expectations for 2025.
    • “If finalized as proposed, the MA changes will lower Humana’s benchmark funding by around 160 basis points compared to a flat rate environment, the health insurer disclosed in a filing with the Securities and Exchange Commissionon Monday.
    • “The discrepancy is because the CMS didn’t factor in persistently elevated medical costs into how it calculates rates, Humana said. However, regulators could do so in the final rule. Despite the uncertainty, the insurer reaffirmed its earnings outlook for 2025.”
  • Per Fierce Healthcare,
    • “Rural providers feel financially stable, with most planning to expand existing service lines to increase revenue, a new survey has found (PDF).
    • “The survey was conducted by accounting firm Wipfli and reached 106 rural healthcare organizations across 26 states. Respondents included a mix of critical access hospitals, rural health clinics and others.
    • “Overall, most respondents are cautiously or completely optimistic about their financial viability. About 40% said their financial stability is higher than it was a year ago, and the portion of those who think they are in a better place than they were five years ago also rose compared to 2023. Despite challenges like high inflation, dwindling COVID-19 relief funds and flat reimbursement rates, growing optimism suggests rural providers learned how to manage unpredictability during the pandemic, the report said. * * *
    • Entering 2024, rural healthcare leaders are most concerned about revenue capture, digital capabilities and people management.
  • HR Morning offers nine tips on maximizing core health benefits.
  • The Society for Human Resource Management discusses best practices for hybrid work models.

Midweek update

Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call informs us
    • “House leadership smoothed the path for consideration of a $78 billion family and business tax break deal Wednesday by committing to a floor vote as soon as next week on a separate bill to boost the state and local tax deduction cap for married couples.”
  • and later
    • “The House on Wednesday night passed a $79 billion family and business tax break bill after several days of uncertainty, teeing it up for consideration in the Senate. 
    • “The package negotiated by House Ways and Means Chairman Jason Smith, R-Mo., and Senate Finance Chair Ron Wyden, D-Ore., easily mustered the two-thirds majority needed to pass, despite GOP drama earlier in the week and previous criticism from Democrats. 
    • “It’s a strong, commonsense, bipartisan step forward in providing urgent tax relief for working families and small businesses,” Smith said on the floor ahead of the 357-70 vote. “Parents in Main Street communities across this country will see lower taxes, more opportunity and greater financial security after we pass this legislation.”
  • Here is a link to today’s hearing held by the House Energy and Commerce Committee’s Health Subcommittee about national healthcare expenditures.
  • Fierce Healthcare tells us,
    • “Medicare Advantage (MA) payments are set to decrease yet again in 2025 as the feds phase in significant changes to risk adjustment.
    • “As those overhauls begin to take effect, benchmark payments are set to decline by about 0.2% on average, according to the latest advance notice released by the Centers for Medicare & Medicaid Services (CMS).
    • “Despite this, the feds said Wednesday that payments to MA plans are expected to increase by 3.7% in 2025, a $16 billion increase over 2024. The payment rate announced today could change by the time the final rate announcement is published, no later than April 1.”
  • The CY 2025 Advance Notice may be viewed by going to: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents and selecting “2025 Advance Notice.”
  • A fact sheet discussing the provisions of the CY 2025 Advance Notice, as well as frequently asked questions, can be viewed here: https://www.cms.gov/newsroom/fact-sheets/2025-medicare-advantage-and-part-d-advance-notice-fact-sheet.
  • Beckers Payer Issues adds,
    • “A bipartisan group of lawmakers is urging CMS to maintain “payment and policy” stability in Medicare Advantage. 
    • “In a letter to CMS Administrator Chiquita Brooks-LaSure, the group of 60 senators asked the agency to “consider the ongoing implementation of program reforms finalized last year and provide stability for the Medicare Advantage program in 2025.”  * * *
    • “The letter comes after two lawmakers, Sen. Elizabeth Warren and Rep. Pramila Jayapal, wrote to the agency urging more action on curbing overpayments to the program. 
    • “Read the full letter here. 
  • Today, OPM posted on the Federal Register website a proposed FEHB rule that “would allow FEHB and PSHB coverage to become effective at the beginning of the pay period that the employee in pay status has an initial opportunity to enroll. This change would occur when the employee becomes eligible for FEHB or PSHB coverage, provided an appropriate request to enroll is received by the employing office within the initial pay period that the employee becomes eligible.”
  • American Hospital News reports,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 issued a final rule that updates certain regulations for Opioid Treatment Programs and the standards for treatment of opioid use disorder. The rule makes some COVID-19-related flexibilities permanent, including take-home doses of methadone, the ability of an OTP to prescribe medication for OUD via telehealth without an initial in-person physical evaluation, and the removal of certain requirements for admission to an OTP to better align with evidence-based practice.”
  • KFF shares three charts about Medicare drug price negotiations.
  • Federal News Network reports,
    • “The Postal Service is looking to cut $5 billion from its operating costs and grow its revenue by the same amount over the next two years to overcome its long-term financial challenges.
    • “Postmaster General Louis DeJoy is telling the White House and Congress that implementing these plans is necessary to keep USPS from running out of cash in the coming years.
    • “DeJoy, in a Jan.10 letter obtained by Federal News Network, told President Joe Biden and congressional leaders that USPS is “utilizing all of the self-help tools that are available to us,” and trying to get back on track with its “break-even” goal, after years of billion-dollar net losses.
    • “It is evident that to break even and avoid running out of cash in the next several years, we must press ahead on our financial improvement initiatives over the next two years,” DeJoy wrote. “While we have already achieved historic reductions, they are simply not enough to make us financially sustainable.”

From the public health and medical research front,

  • Check out this JAMA Open article to learn why “Paxlovid Is Effective but Underused—Here’s What the Latest Research Says About Rebound and More.”
  • Per Fierce Healthcare,
    • “As artificial intelligence advances in different areas of healthcare, there are concerns that technology and AI-based chatbots will replace the human connections between patients and practitioners.
    • “But, a new study finds promising potential for AI and large language models to enhance mental health therapy at scale by being able to analyze millions of text-based counseling messages to shine a light on what works.
    • “Researchers used AI to analyze more than 20 million text conversations of counseling sessions and successfully predicted patient satisfaction and clinical outcomes, according to a study published this week in the Journal of The American Medical Association (JAMA) Open.”
  • The National Institutes of Health announced,
    • An analysis conducted by the National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH) reveals a substantial increase in the overall use of complementary health approaches by American adults from 2002 to 2022. The study, published in the Journal of the American Medical Association, highlights a surge in the adoption of complementary health approaches for pain management over the same period.
    • Researchers utilized data from the 2002, 2012, and 2022 National Health Interview Survey (NHIS) to evaluate changes in the use of seven complementary health approaches, including yoga, meditation, massage therapy, chiropractic care, acupuncture, naturopathy, and guided imagery/progressive muscle relaxation.
    • The key findings include:
      • The percentage of individuals who reported using at least one of the seven approaches increased from 19.2% in 2002 to 36.7% in 2022.
      • The use of yoga, meditation, and massage therapy experienced the most significant growth from 2002 to 2022.
      • Use of yoga increased from 5% in 2002 to 15.8% in 2022.
      • Meditation became the most used approach in 2022, with an increase from 7.5% in 2002 to 17.3% in 2022.
      • Acupuncture, increasingly covered by insurance, saw an increase from 1% in 2002 to 2.2% in 2022.
    • Additionally, the analysis showed a notable rise in the proportion of U.S. adults using complementary health approaches specifically for pain management. Among participants using any of the complementary health approaches, the percentage reporting use for pain management increased from 42.3% in 2002 to 49.2% in 2022.
    • Despite the findings, the authors acknowledge study limitations, including decreasing NHIS response rates over time, possible recall bias, cross-sectional data, and differences in survey wording.
  • and
    • “Researchers at the National Institutes of Health detected abnormal proteins in the spinal fluid of people with amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), which could help improve diagnosis of these diseases. The findings were published in Science Translational Medicine.
    • “The proteins in question are built from “cryptic” exons—abnormal portions of RNA, the cell’s instructions for how to build proteins. Cryptic exons occur when TDP-43, a protein that regulates how RNA is processed, stops functioning normally. TDP-43 dysfunction is linked to ALS, FTD, Alzheimer’s disease, and Limbic Associated TDP-43 Encephalopathy (LATE).
    • “The study showed that these mis-spliced sections of RNA can sometimes generate new proteins from the cryptic sequence. The findings advance our understanding of how cryptic exons may be involved in the dementia disease process and could help identify diseases involving TDP-43 dysfunction before symptoms appear. Currently, TDP-43 aggregates in the brain can only be detected at autopsy.”  
  • MedPage Today points out, “Getting clinicians to commit to the Choosing Wisely recommendations somewhat reduced low-value care for older adults in common scenarios, a cluster randomized trial found.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Nordisk has resumed shipping starter doses of its weight-loss drug Wegovy, nearly nine months after manufacturing problems forced it to restrict distribution to maintenance shots in order to ensure that people who had already started taking it could continue, the company said Wednesday.
    • “The resumption of the starter doses, which begin at 0.25 milligrams per week, comes two months after obesity rival Eli Lilly gained U.S. approval for a competing drug, Zepbound, that could threaten to eat away at Novo’s sizable lead in weight-loss treatment.”
  • The Wall Street Journal adds,
    • “Nearly every employer in the country is now grappling with how—and whether—to pay for new weight loss drugs. Needless to say, such decisions are highly important to patients struggling with obesity.
    • “But for Eli Lilly and Novo Nordisk, it actually doesn’t matter, for now, from a financial perspective. They are selling every injection they can make. It won’t change anytime soon.” ***
    • While the companies are both moving as fast as possible, expanding the manufacturing of injectables is complicated. 
    • “You’re talking about billions of pens. That’s not a trivial exercise,” says Guggenheim analyst Seamus Fernandez. “Producing pens is a very complex process that requires precision and lots of attention to safety.” 
    • “That is one reason why developing pills such as Lilly’s orforglipron, which is undergoing clinical trials, is so crucial, he adds. Figuring out how to make oral versions well-tolerated is a challenge, though.”
  • MedTech Dive tells us about the top medtech trends in 2024. “Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year.”
  • Per Healthcare Dive,
    • “Cigna has agreed to sell its Medicare business to Health Care Service Corporation for roughly $3.7 billion, the health insurer announced Wednesday.
    • HCSC is acquiring Cigna’s Medicare Advantage, supplemental benefits and Medicare Part D plans, along with CareAllies, a division that helps providers transition to value-based care. In total, the plans cover 3.6 million people on Medicare.
    • “The companies said they expect the deal — which includes $3.3 billion in cash and $400 million in capital Cigna expects to be freed up — to close in the first quarter of 2025, subject to regulatory approval.”
  • and
    • “Humana plans to expand its primary care network for seniors this year, as the insurer looks to lean on provider capabilities to boost its beleaguered Medicare Advantage business.
    • “In 2024, CenterWell Senior Primary Care plans to enter three new markets in North Carolina and Louisiana, and add additional centers in eight of its current markets in the U.S., the payer announced on Tuesday.
    • “Humana is one of many health insurers racing to build out a provider network to provide convenient access to primary care for its members. But for Humana, this strategy is more important than it might be for its rivals with a broader variety of plans, given Humana has made such a significant bet on Medicare Advantage, said Arielle Trzcinski, a healthcare analyst at market research firm Forrester.”
  • BioPharma Dive lets us know,
    • In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of Alzheimer’s disease. Developed by partners Biogen and Eisai, the medicine, called Aduhelm, was viewed initially as a needed new treatment option by patients and a potential blockbuster product by Wall Street analysts.
    • “Now, less than three years since that approval, Biogen is fully giving up on the drug. The company said Wednesday it is handing rights to back to Aduhelm’s original developer, Neurimmune, and will redirect much of the money spent on the drug toward other Alzheimer’s therapies in its business.
    • “Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” said Christopher Viehbacher, the company’s CEO, in a statement.”
  • Per Beckers Payer Issues,
    • “The share of U.S. employees in healthcare plans funded by their employer rose from 2015 to 2021, a study published in the January issue of Health Affairs found. 
    • “In 2015, 55% of employees were enrolled in self-funded plans, compared to 60% of employees in 2021. Most of the growth occurred in states and counties with lower levels of self-funded enrollment, the study found. 
    • “Groups of rapid growth in self-funded plans were concentrated in Arkansas, New York, Northern California, Pennsylvania and Utah, the study found. 
    • “Elevance Health is the largest administrator of self-funded plans, with around 19% of the total market, according to the study. CVS Health claimed the fastest growing self-funded enrollment from 2015 to 2021. “

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced today that
    • “Sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, which was initially announced in February 2023. The model is designed to improve health outcomes, increase access to cell and gene therapies, and lower health care costs for some of the nation’s most vulnerable populations. * * *
    • “Gene therapies for sickle cell disease have the potential to treat this devastating condition and transform people’s lives, offering them a chance to live healthier and potentially avoid associated health issues,” said CMS Administrator Chiquita Brooks-LaSure. “Increasing access to these promising therapies will not only help keep people healthy, but it can also lead to savings for states and taxpayers as the long-term costs of treating sickle cell disease may be avoided.” * * *
    • “For additional information see the fact sheet – PDF and CGT model page.
  • The American Hospital Association reports,
    • “Paxlovid may no longer be distributed with an emergency use label after March 8, the Food and Drug Administration announced. Providers may dispense unexpired Paxlovid labeled for emergency use to patients through March 8, after which Paxlovid labeled for emergency use must be returned to the manufacturer or disposed of in accord with regulations, the agency said.
    • “The FDA last May approved a new drug application for Pfizer’s Paxlovid to treat adults at high risk of progressing to severe COVID-19. Paxlovid labeled under the new drug application will continue to be authorized for emergency use to treat eligible pediatric patients, the agency said.”
  • Following up on Affordable Care Act FAQ 64, the U.S. Office of Personnel Management issued today a carrier letter no. 2024-03 on contraceptive coverage and patient education.
  • Reuters reports,
    • “Pharmaceutical companies are due to receive by Thursday the U.S. government’s opening proposal for what are expected to be significant discounts on 10 of its high-cost medicines, an important step in the Medicare health program’s first ever price negotiations.
    • “Five Wall Street analysts and two investors told Reuters they expect the negotiations over prices that will go into effect in 2026 to result in cuts ranging from the statutory minimum of 25% to as much as 60% when the final numbers are set in September.
    • “The drugmakers and the government are expected to wait until then to disclose them.” * * *
    • “Pharmaceutical companies and business groups have filed more than half a dozen lawsuits to stop the negotiations from taking place, saying that they are unlawful.
    • “Drug companies say the law’s costs will hurt drug development programs and patients.”
    • “The lawsuits have not slowed the implementation timeline.”
  • Axios points out that CMS’s recent prior authorization proposed rule do not apply to prescription drug claims.
  • The Federal Acquisition Regulation Council published in the Federal Register today a proposed rule
    • “would prohibit contractors and subcontractors from seeking and considering information about job applicants’ compensation history when making employment decisions for certain positions. Under the proposed policy and the proposed regulatory amendments, contractors and subcontractors would also be required to disclose the compensation to be offered to the hired applicant in job announcements for certain positions.”
  • The public comment period ends on April 1, 2024.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “People who are suffering from severe pain but don’t want to risk addiction to an opioid are closer to a new option for treatment.
    • Vertex Pharmaceuticals on Tuesday reported positive study results for its closely watched non-opioid painkiller. The drug lowered the moderate-to-severe acute pain reported by study volunteers, a sign it could be the first in a new class of painkiller to be approved for use.
    • “But the experimental medicine is more likely to provide an alternative to opioids, rather than supplant them, because it didn’t work better than a widely used opioid drug sold under the brand name Vicodin.
    • “Vertex said it would file for approval from the U.S. Food and Drug Administration by the middle of this year.”
  • STAT News tells us,
    • “Drugs like Ozempic and Wegovy — already game changers for diabetes and obesity — are being studied to treat an entirely different growing health problem: mental health illnesses, including depression and bipolar disorder.
    • “Early data and anecdotes suggest that this class of GLP-1 drugs could help patients feel less depressed and anxious. The treatment may also fight the decline in cognitive and executive function that many people with mental health disorders experience, like worsening memory and losing the ability to focus and plan.
    • “If further research yields positive results, it could drive even more demand for the highly popular GLP-1 treatments, which have increasingly been shown to help with problems across the body, such as heart and kidney complications. And especially if the cognitive benefits are proven out, the GLP-1 drugs would plug a critical gap in current treatments for depression, since most depression drugs help with mood, but close to none address cognitive symptoms that affect memory and attention.”
  • and
    • “The U.S. syphilis epidemic isn’t abating, with the rate of infectious cases rising 9% in 2022, according to a new federal government report on sexually transmitted diseases in adults.
    • “But there’s some unexpected good news: The rate of new gonorrhea cases fell for the first time in a decade.
    • “It’s not clear why syphilis rose 9% while gonorrhea dropped 9%, officials at the U.S. Centers for Disease Control and Prevention said, adding that it’s too soon to know whether a new downward trend is emerging for the latter.
    • “They are most focused on syphilis, which is less common than gonorrhea or chlamydia but considered more dangerous. Total cases surpassed 207,000 in 2022, the highest count in the United States since 1950, according to data released Tuesday.”
  • MedTech Dive calls attention to “four heart device trends shaping the medtech sector in 2024. Medtronic, Boston Scientific and J&J are among the medtech companies advancing treatments in cardiac care for when medicines are not enough.
  • MedCity Dive discusses “How Food as Medicine is Becoming A Core Team Capability. As the food as medicine movement grows, some payers and healthcare organizations are carving out specific roles and teams dedicated to food and nutrition. Doing so can be beneficial considering the significant impact diet can have on health outcomes.”
  • The Washington Post notes,
    • “Older adults spend an average of three weeks every year on doctor’s appointments and other health care outside their homes, according to research published in the Annals of Internal Medicine.
    • “Of those 21 “health care contact days,” 17 involve ambulatory services, such as office visits with primary-care doctors or specialists, testing and imaging, procedures, treatments and therapy. The remaining four days included time spent in an emergency room, hospital, skilled nursing facility or hospice.
    • “The study also found that about 11 percent of people 65 and over spend even more time — 50 or more days each year (nearly one day a week) — obtaining routine health care away from home. The research was based on Medicare data from a nationally representative sample of 6,619 people 65 and older.
    • “The findings represent “not only access to needed care but also substantial time, efforts and cost, especially for older adults and their care partners,” the researchers wrote.”
  • Peterson – KFF Health System Tracker offers a study comparing U.S. life expectancy to other countries.

From the U.S. healthcare business front,

  • Pfizer released its full year 2023 results and reaffirmed its full year 2024 financial guidance provided on December 13, 2023. “The fourth-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.”
  • Beckers Hospital Review reports,
    • “Nashville, Tenn.-based HCA Healthcare saw revenues of $17.3 billion in the fourth quarter of 2023, up from $15.5 billion over the same period in 2022, according to its financial report released Jan. 30.” 
  • and
    • “Nonprofit Hospitals’ operating margins are far below the pre-pandemic “magic number” of 3% and are in danger of a permanent reset in the 1%-2% range, according to a Jan. 29 report published by Fitch Ratings.
    • “This operating margin reset is worrying some investors, but “hospital downgrades en masse would be unlikely because many systems have built up robust balance sheets and learned to economize on capital spending to a certain degree,” Kevin Holloran, senior director and sector head at Fitch, said.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington DC,

  • Healthcare Dive reports,
    • “A group of bipartisan senators on Wednesday reintroduced a bill that aims to remove barriers to telemental healthcare for Medicarebeneficiaries.
    • “The legislation, introduced by Sens. Bill Cassidy, R-La., Tina Smith, D-Minn., John Thune, R-S.D., and Ben Cardin, D-Md., would remove requirements that telemental health patients see an in-person provider within six months of receiving services via telehealth.
    • “The senators warned the “arbitrary” requirement that patients be seen in-person will limit access to needed care, particularly in rural areas.”
  • The Senate Finance Committee lets us know,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today announced their commitment to working on bipartisan health care legislation to prevent and mitigate shortages of critical generic drugs used by patients and providers in the United States.
    • “In a white paper released today, Wyden and Crapo outline concerns raised by experts at a hearing held in the Finance Committee on December 5, 2023, as well as areas of interest and ideas the Committee is exploring to address the factors contributing to shortages through modifications to the Medicare and Medicaid programs. * * *
    • The white paper can be found here.
  • and
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Finance Committee Members Chris Coons (D-Delaware), Tom Carper (D-Delaware) and Thom Tillis (R-North Carolina), along with ten of their colleagues, wrote today to President Biden urging him to reject the proposal before the World Trade Organization (WTO) that would waive intellectual property (IP) protections for COVID-19 diagnostics and therapeutics.  Waiving protections afforded by the WTO Agreement on Trade-Related Aspects of IP Rights (TRIPS) could have unintended consequences for the development of new treatments for dangerous diseases, while doing little to improve access to medicine.”
  • HHS’s Human Resource & Services Administration tells us,
    • “Today, Health Resources and Services Administration (HRSA) Administrator Carole Johnson, joined by Rep. Lauren Underwood (D-IL), co-chair of the Black Maternal Health Caucus, launched a year-long Enhancing Maternal Health Initiative. The initiative will strengthen, expand, and accelerate HRSA’s maternal health work to address maternal mortality and maternal health disparities in partnership with mothers, grantees, community organizations, and state and local health officials across the country.
    • “The kick-off event at the Kaiser Family Foundation in Washington, DC, convened HRSA maternal health grantees from 11 states and the District of Columbia, as well as key national organizations and experts, providers, and individuals with lived experience. Attendees shared personal perspectives on maternal health care and support, the innovative ways HRSA grantees are making an impact on maternal health, and how they are addressing maternal mental health. * * * For more information on HRSA’s maternal health work, visit: www.hrsa.gov/maternal-health.”
  • The Government Accountability Office issued a report on OPM’s paid parental leave program.
    • “Starting October 1, 2020, most federal civilian employees became eligible to take up to 12 weeks of paid parental leave for the arrival of a new child whether by birth, adoption, or foster care.
    • “The Office of Personnel Management’s government-wide data showed that most federal employees were aware of the benefit, and the number of employees who took paid parental leave generally aligned with OPM’s initial estimates.
    • “However, OPM’s webpage for federal leave policies is outdated and doesn’t include information about the benefit. We recommended that OPM update guidance on its webpage to help ensure employees better understand their eligibility.”
  • FedWeek explains how to weigh the options if separating from a spouse before federal employee retirement eligibility.
  • Per Healthcare Dive,
    • “The Federal Trade Commission sued to block Novant Health’s $320 million acquisition of two North Carolina hospitals from Community Health Systems on Thursday, alleging the deal threatens to raise consumer prices and reduces incentives to provide quality care.
    • “The antitrust agency said the proposed deal, which was first announced in February of last year, would reduce competition in the region and “increase annual healthcare costs by several million dollars.”
    • “In response to the lawsuit, a representative from Winston-Salem, North Carolina-based Novant said the nonprofit system would “pursue available legal responses to the FTC’s flawed position.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for preventing spontaneous early births, a major health concern for which there are no good treatments.
    • “At the two-day workshop led by the FDA and and the Duke-Margolis Center for Health Policy, experts in maternal and fetal health, as well as advocates, discussed challenges to developing a medicine for preterm births, which affect 1 in every 10 babies in the U.S. and can jeopardize their health.”
  • Per MedTech Dive,
    • “Abbott received approval from the Food and Drug Administration for a rechargeable deep brain stimulation (DBS) system.
    • “Abbott claimed in the Thursday announcement its device, called Liberta RC, is the world’s smallest and has the longest charge of any DBS technology on the market. The company says the device only needs to be recharged 10 times per year under standard settings for most users. 
    • “Earlier this month, Medtronic also received approval for a new DBS system called Percept RC, which has sensing technology to track patients’ response to treatment.”

From the public health and medical research front,

  • HCPLive alerts us,
    • “Despite being the leading cause of death in the US for more than a century, more than half of the respondents to a 2023 survey conducted on behalf of the American Heart Association (AHA) failed to identify heart disease as the leading killer of US adults, according to the AHA’s 2024 Heart Disease and Stroke Statistics report.
    • “Data from the report, which is created annually by the AHA and National Institutes of Health to spotlight the impact of heart disease and stroke in the US and abroad, highlight a lack of awareness surrounding the impact of cardiovascular disease, with additional statistics paint a picture where 51% failed to identify heart disease as the leading cause of death, but also spotlights how advances in care and education have caused death rates from cardiovascular disease to decline by 60% in the last 75 years.”
  • The Society for Human Resource Management offers advice on “a number of policies and strategies employers might want to turn to during this coronavirus and flu surge.”
  • Beckers Hospital Review informs us,
    • “The CDC has rejected findings from Ohio State University researchers that the JN.1 coronavirus variant is more severe than previous strains.
    • “While JN.1 currently accounts for almost 86% of current COVID-19 cases in the U.S., the CDC published a statement Jan. 22 saying that the agency has found “no evidence that it causes more severe disease,” adding that vaccines are still expected to increase protection against the variant as well.
    • “The Ohio State University research, published Jan. 8 in Cell, had focused on two subvariants: BA.2.86 and JN.1. Their study found that it “appears to have increased infectivity of human lung epithelial cells compared to all omicron variants…(which) raises a potential concern about whether or not this virus is more pathogenic,” Shan-Lu Liu, MD, PhD, senior author the study and a virology professor at OSU stated in a news release about the research.  
    • “Since JN.1 is an offspring of BA.2.86, OSU researchers found it had similar results.
    • “While the CDC does not align with this research, the agency did state it “is contributing to the spread of COVID-19 this winter.”
  • STAT News reports,
    • “Building off of some landmark discoveries published last year, researchers have mapped out the biological underpinnings of Parkinson’s disease, creating a framework for medicines that might treat the root of the disease rather than just its symptoms.
    • “Their work, published in the Lancet Neurology, stages Parkinson’s based on the accumulation of a misfolded protein called alpha-synuclein. Funded by the Michael J. Fox Foundation for Parkinson’s Research, the work expands on a 2023 publication that validated an alpha-synuclein diagnostic for the disease.
    • “The new framework still has some gaps, but the researchers believe they’ve set out a path that will allow scientists to discover and rigorously test treatments aimed at the biological causes of Parkinson’s, providing a reliable measure of disease severity that might accelerate the process of drug development.”
  • The Institute for Clinical and Economic Review posted,
    •  “its revised Evidence Repor assessing the comparative clinical effectiveness and value of xanomeline tartrate/trospium chloride (KarXT, Karuna Therapeutics) for the treatment of schizophrenia. 
    • “Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves,” said ICER’s Chief Medical Officer, David Rind, MD. “Among the important side effects of current treatments is weight gain leading to metabolic syndrome. This, in turn, places patients at risk for cardiovascular events and death. KarXT has a novel mechanism of action and, at least in the short run, does not seem to cause weight gain. This may lead to major health benefits compared with existing treatments, however current evidence on benefits and harms is limited.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC (New England CEPAC) on February 9, 2024. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • Healio calls our attention to these study findings:
    • “Adults who lose weight in the year after being diagnosed with type 2 diabetes are more likely to achieve diabetes remission.
    • “Weight regain after remission increases the risk for returning to hyperglycemia.” 

From the U.S. healthcare business front,

  • The Raleigh (NC) News and Observer reports,
    • “Facing unsustainable costs, the NC State Health Plan’s board of trustees voted to end all plan coverage of popular weight-loss drugs beginning April 1. Board members met Thursday afternoon to consider options for how the plan could deal with rising costs. In October, the board imposed a moratorium on new prescriptions for one of the drugs, Wegovy, when made solely for weight-loss purposes. The moratorium began Jan. 1. At the conclusion of the lengthy meeting, the board voted 4-3 to exclude all coverage of obesity GLP-1 medications on April 1.
    • This will end coverage for plan members who were grandfathered in and already taking the medications as well. Usage of Wegovy, Saxenda and other drugs by plan members has increased significantly in recent years, as have costs incurred by the plan. The plan spent a projected $102 million on these drugs in 2023, or 10% of its roughly $1 billion in net pharmacy spending last year.
  • It stuns the FEHBlog that Novo Nordisk and Eli Lilly continue to raise prices for their GLP-1 drugs when they have blockbuster aales.
  • The American Hospital News notes,
    • “Hospitals and health systems are prioritizing preserving access to care for patients in rural America, including via access points like hospital outpatient departments that provide essential services for rural and low-income communities, according to a new AHA report released Jan. 25. The report details how hospitals have been a lifeline for struggling rural physician practices helping to keep their doors open, and HOPDs have remained convenient, high-quality access points for rural patients with more complex care needs. Among other findings, hospitals were two and a half times more likely to acquire physician practices in rural areas than other entities, including commercial insurers which are overwhelmingly focuse”d on larger and more profitable markets.”
  • Healthcare Dive points out,
    • “Humana on Thursday released a profit outlook for 2024 that fell well short of Wall Street’s already-diminished expectations, as the health insurer continues to be plagued by high medical spending on seniors.
    • “The Louisville, Kentucky-based payer expects to bring in $16 in adjusted earnings per share in 2024 — a whopping $13 short of analysts’ consensus expectations. In comparison, Humana brought in $26.09 in adjusted earnings per share this year.
    • “Humana also rescinded its earnings target for 2025. The health insurer’s stock plunged 15% in morning trade Thursday following the results.”
  • and
    • “Cleveland Clinic executives applauded the operator’s financial rebound in an annual State of the Clinic address, but signaled it would continue lean operations to chase sustained profitability.
    • “We sustain and advance Cleveland Clinic’s mission by serving patients and managing our resources,” said Tom Mihaljevic, Cleveland Clinic CEO and president, during the Wednesday address. “It is possible to use fewer resources while touching more lives.”
    • “Cleveland Clinic exceeded its revenue projections for 2023, drawing in over $14 billion in revenue on more than 14 million annual patient interactions, according to Mihaljevic.
    • “The Ohio-based nonprofit reported an operating margin of 0.4% for the year — an improvement on the prior year’s performance, when the Clinic reported an operating margin of -1.6% on a $1.2 billion net loss.” 

Midweek Update

Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced that
    • “21.3 million people selected an Affordable Care Act Health Insurance Marketplace plan during the 2024 Open Enrollment Period. Total plan selections include more than five million people — about a fourth — who are new to the Marketplaces and 16 million people who renewed their coverage. Notably, open enrollment continues in four states and Washington, D.C., through January 31.
    • “For decades, when it came to federal programs we could depend on to keep Americans covered, three were always top of mind — Medicare, Medicaid, and Social Security, but now it’s crystal clear that we need to add a fourth — the Affordable Care Act,” said HHS Secretary Xavier Becerra. “Once again, a record-breaking number of Americans have signed up for affordable health care coverage through the Affordable Care Act’s Marketplace, and now they and their families have the peace of mind that comes with coverage. The ACA continues to be a successful, popular, and important federal program to millions of people and their families. As we celebrate the success of this most recent enrollment effort, HHS will double down on the Biden-Harris Administration’s efforts to increase access to quality care and lower costs.”
  • The Peterson-KFF Health System Tracker identifies “Health Cost and Affordability Policy Issues and Trends to Watch in 2024.”

From the public health and medical research front,

  • Beckers Hospital Review informs us,
    • “After discontinuing the use of semaglutide and liraglutide weight-loss medications, a majority of patients were able to maintain the same weight they were at when halting the use — or even continued to lose additional weight after one year, a new study revealed. 
    • “The research, published Jan. 23 in Epic Research, focused on the outcomes of 20,274 patients who were prescribed semaglutide and 17,733 patients prescribed liraglutide, who lost at least five pounds while taking it. 
    • “Sustained weight loss slightly differed for the drugs — 56.2% of patients prescribed semaglutide kept the weight off one year after discontinuation of the drug, while that same outcome was 55.7% of patients who took liraglutide.
    • “While the majority were able to maintain their weight or shed additional pounds, some did not, and the outcomes differed by medication type. 
    • “One year after discontinuation of semaglutide medications, 17.7% regained all the weight they had lost while on the medication, and some even gained additional weight. For liraglutide, 18.7% entirely regained their weight one year after halting use.
  • Medpage Today tells us,
    • “Infants born to unvaccinated mothers who had COVID-19 during pregnancy were at high risk for developing neonatal respiratory distress, the longitudinal, cohort COMP study found.
    • “The odds of developing respiratory distress were threefold higher (OR 3.06, 95% CI 1.08-10.21) in infants born to unvaccinated mothers diagnosed with COVID-19 while pregnant compared with COVID-exposed infants born to COVID-vaccinated mothers, Mary Catherine Cambou, MD, of the University of California Los Angeles (UCLA), and colleagues reported in Nature Communications.
    • “This was not something we were expecting to see, as none of the babies were diagnosed with COVID-19 themselves,” co-author Karin Nielsen-Saines, MD, also from UCLA, told MedPage Today in an email. “We also noted that respiratory distress was not transient and lasted several days.”
    • “However, when pregnant participants had received at least one mRNA vaccine dose prior to SARS-CoV-2 infection, the odds of their infants developing neonatal respiratory distress dropped to 0.33 (95% CI 0.10-0.96) — a 67% decline, the authors pointed out.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health have found overactivation in many brain regions, including the frontal and parietal lobes and the amygdala, in unmedicated children with anxiety disorders. They also showed that treatment with cognitive behavioral therapy (CBT) led to improvements in clinical symptoms and brain functioning. The findings illuminate the brain mechanisms underlying the acute effects of CBT to treat one of the most common mental disorders. The study, published in the American Journal of Psychiatry, was led by researchers at NIH’s National Institute of Mental Health (NIMH). 
    • “The findings can help our understanding of how and for which children CBT works, a critical first step in personalizing anxiety care and improving clinical outcomes,” said senior author Melissa Brotman, Ph.D., Chief of the Neuroscience and Novel Therapeutics Unitin the NIMH Intramural Research Program. * * *
    • “This study provide evidence—in a large group of unmedicated youth with anxiety disorders—of altered brain circuitry underlying treatment effects of CBT. The findings could, in time, be used to enhance treatment outcomes by targeting brain circuits linked to clinical improvement. This is particularly important for the subset of children who did not significantly improve after short-term CBT.
    • “The next step for this research is to understand which children are most likely to respond. Are there factors we can assess before treatment begins to make the most informed decisions about who should get which treatment and when? Answering these questions would further translate our research findings into clinical practice,” said Brotman.”
  • BioPharma Dive reports,
    • “An 11-year-old boy who was born deaf can hear after receiving an experimental gene therapy, developer Eli Lilly reported on Tuesday.
    • “The boy, identified as Aissam Dam by The New York Times, was the first participant treated in a small study Lilly is running to test the therapy, which is designed to correct a particular type of inherited hearing loss.
    • “While only from one person, the result is a striking example of gene therapy’s potential. According to Lilly, Dam experienced restored hearing across sound frequencies within a month of treatment. In some frequencies, Dam’s hearing was within the normal range at day 30, Lilly said.
    • “Lilly plans to present full data from Dam, as well as a second participant in its study, at a medical conference in early February.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Elevance Health raked in $6 billion in profit last year on revenue of more than $171 billion — a better performance than Wall Street expected, given that high medical costs have been dogging payers.
    • “The payer beat analysts’ consensus expectations for earnings and revenue in the fourth quarter of 2023, with a topline of $42.7 billion, up 7% year over year. Elevance’s fourth-quarter profit of $831 million was down, however, by 5% year over year.
    • “Elevance chalked its revenue growth up to higher premiums and growth in its pharmacy benefit manager CarelonRx. Analysts said the Indianapolis, Indiana-based payer also benefited from better-than-expected medical costs and higher investment income in the quarter.” 
  • and
    • “Walgreens is considering a sale of its specialty pharmacy business Shields Health Solutions as the struggling retail chain attempts to improve its halting finances, according to a Bloomberg report. 
    • “Shields could be valued at more than $4 billion in a sale, and a deal might appeal to private equity firms or healthcare companies, Bloomberg said, citing sources familiar.
    • “Walgreens is in the midst of a shift to focus on delivering healthcare services to payer, provider and pharmaceutical clients. But the company’s U.S. Healthcare division — which Shields is a part of — isn’t currently profitable.” 
  • and
    • “HCA Healthcare’s outpatient surgery operator Surgery Ventures has acquired majority interests in two ambulatory surgical centers in North Texas, the for-profit hospital operator announced on Monday.
    • “The centers are now affiliated with HCA subsidiary Medical City Healthcare, which runs 19 hospitals and 15 surgery centers in the region.
    • “The purchase comes after HCA, one of the largest hospital operators in the country, has made other recent acquisitions in Texas, which is one of the chain’s largest markets.” 
  • Per BioPhama Dive,
    • “Johnson & Johnson CEO Joaquin Duato sold 2023 as a “remarkable year” on an earnings call with investors Tuesday. But the pharmaceutical giant faces looming difficulties that hang over its performance, including incoming biosimilar competition to its blockbuster immune drug Stelara and a $700 million settlement over claims the company’s talc product caused cancer.
    • “As far as last year goes, J&J narrowly beat Wall Street’s expectations with $85.2 billion in revenue. Pharma sales grow 9.5% in the fourth quarter compared to the same period the year before. Cancer treatments and immunology medicines like Stelara made up the bulk of that revenue.
    • “As one of the largest pharma companies and often the first in the sector to report earnings each quarter, J&J is often considered a sort of bellwether for the industry.”
  • and
    • “Novo Nordisk is adding yet another prospect to its obesity drug pipeline, this time from a biotech company spun out of Harvard University and Zurich University. · EraCal Therapeutics tests compounds in larval zebrafish in a bid to trigger behavioral changes related to appetite while minimizing other effects in the body. The Swiss startup says it’s seen early success in mice and may be able to produce a drug that helps people lose weight without the side effects sometimes seen with current treatments. ·
    • “As part of the deal announced Tuesday, EraCal is eligible for payments worth as much as 235 million euros, or about $256 million, as well as royalties if a product reaches the market. The total includes an unspecified amount of money up front, as well as future payments tied to developmental and commercial milestones.”
  • North Carolina Public Radio reports
    • “The board that oversees the North Carolina State Health Plan will face a heavy decision Thursday when it considers dropping coverage of weight loss medications like Wegovy. * * *
    • “The State Health Plan is the health insurance plan for more than 740,000 teachers, state employees, retirees, and their dependents. It’s a massive health plan that paid more than $4 billion in claims last fiscal year, according to plan data.
    • “But even at that size, the high costs of these GLP-1 medications take an outsized bite of the pie. In 2023, the 24,750 people with prescriptions of Wegovy, Saxenda, and Zepbound cost the plan $102 million after rebates. In 2024, CVS Caremark, the plan’s pharmacy benefits manager, warned those rebates might lessen or go away completely, something that could push total costs north of $170 million. For context, as recently as 2019-20, the plan paid less than $790 million for all pharmacy claims for the entire fiscal year.”
  • Bolton consulting group identifies seven key employee benefit trends for this year.